Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

FDA regulation on Overage of drug product [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-05-18 23:05 (5136 d 08:55 ago) – Posting: # 8586
Views: 4,455

Hi everyone,

Does anyone know if FDA has a guidance on overage of a drug product? Example, OROS drug products have overage. Is there a limit as to how much overage is allowed?

Thanks

John

Complete thread:

FDA regulation on Overage of drug productjag009 2012-05-18 21:05 [Regulatives / Guidelines]
- FDA regulation on Overage of drug product Helmut 2012-05-19 02:02
  - FDA regulation on Overage of drug product jag009 2012-05-21 15:19

Admin contact
23,653 posts in 4,991 threads, 1,570 registered users;
208 visitors (0 registered, 208 guests [including 22 identified bots]).
Forum time: 08:00 CEST (Europe/Vienna)

There are no dangerous thoughts;
thinking itself is dangerous. Hannah Arendt

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz